Distal protection device

ABSTRACT

The present invention describes a catheter suitable for introduction into a tubular tissue for dissolving blockages in such tissue. The catheter is particularly useful for removing thrombi within blood vessels. In accordance with the preferred embodiments, a combination of vibrating motion and injection of a lysing agent is utilized to break up blockages in vessels. The vessels may be veins, arteries, ducts, intestines, or any lumen within the body that may become blocked from the material that flows through it. As a particular example, dissolution of vascular thrombi facilitated by advancing a catheter through the occluded vessel, the catheter causing a vibrating, stirring action in and around the thrombus usually in combination with the dispensing of a thrombolytic agent such as urokinase into the thrombus. The catheter has an inflatable or expandable member near the distal tip which, when inflated or expanded, prevents the passage of dislodged thrombus around the catheter. The dislodged portions of thrombus are directed through a perfusion channel in the catheter, where they are removed by filtration means housed within the perfusion channel before the blood exists the tip of the catheter. Catheters that allow both low frequency (1-100 Hz) vibratory motion and delivery of such agents to a blockage and a method for using such catheters are disclosed. A distal protection system comprising a braided structure capable of moving from a contracted condition to an expanded condition and adapted to inhibit particles from moving completely through the braided structure when expanded is also disclosed.

RELATED APPLICATIONS

[0001] The present application is a continuation of application Ser. No.09/640,499 filed on Aug. 16, 2000, which was a continuation ofapplication Ser. No. 09/005,217, filed on Jan. 9, 1998, now U.S. Pat.No. 6,287,271 which was a continuation-in-part of application Ser. No.08/483,071, filed on Jun. 7, 1995, now U.S. Pat. No. 5,713,848, whichwas a continuation-in-part of application Ser. No. 08/320,184, filed onOct. 7, 1994, now U.S. Pat. No. 5,498,236, which was a continuation ofapplication Ser. No. 08/065,470, filed on May 19, 1993, now U.S. Pat.No. 5,380,273, which was a continuation-in-part of application Ser. No.07/885,665, filed on May 19, 1992, now abandoned, the full disclosuresof which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention is generally directed to removal ofblockage of tubular tissue and specifically directed to the dissolutionof intravascular thrombi.

[0004] 2. Description of the Background Art

[0005] It is well known that the formation of thrombi (clots) in bloodvessels is a serious medical malady. Thrombi are correlated to theformation of plaque buildup in blood vessels and when blockage occurs,it is more a result of the thrombi than of the plaque buildup (which isusually referred to as atherosclerosis when it is involved in arteries).

[0006] All thrombi need not be treated interventionally, but in manyinstances thrombi do, in fact, become life threatening and requireremoval or at least reduction in size. A thrombus is primarily comprisedof red blood cells and fibrin There are several treatments which couldbe adapted for the removal of thrombi in vessels which involveintravascular catheters. Most such intravascular catheters have beendesigned primarily for plaque removal and contain an element thatvibrates at ultrasonic frequencies. Representative of such atherectomycatheters are U.S. Pat. Nos. 5,069,664, 4,920,954, 4,898,575, and4,808,153. Some involve cutting the plaque off of the wall of the vesselusing a cutting blade. Some may be adapted to facilitate removal of athrombus in a vessel. For example, DonMicheal, et al., in U.S. Pat. No.4,870,953, describes an intravascular catheter having a bulbous head atits distal end which vibrates at ultrasonic frequencies. It is suggestedthat such a tip might be useful for disintegrating a thrombus.DonMicheal, et al., also teaches the discharge of a radiographiccontrast medium from the catheter tip to enable visualization of thecleared vessel. A second cooling solution may be circulated through thecatheter to the tip to prevent overheating of the bulbous tip. All theforegoing intravenous catheters have their shortcomings. None areparticularly adapted for removing thrombi.

[0007] The use of laser catheters for treatment of thrombi is notuncommon, and significant damage to vessels during this treatment havebeen reported. The use of drugs for the primary dissolution of theseclots is extremely common and is often considered the primary treatmentof choice when a thrombus is present. These drugs are referred to asthrombolytic agents (meaning clot dissolution or decomposition). Themost common thrombolytic agents (drugs) that are used presently in thetreatment of vascular thrombosis are such agents as urokinase,streptokinase, TPA, leech saliva and other such pharmaceutical clotdissolving agents. Significant problems such as hemorrhagiccomplications, early rethrombosis, prolonged infusion times, costs,significant failure rates, etc., are persistent problems with the use ofthese pharmaceutical agents. To overcome the aforesaid problems withdrugs, an intravascular spraying catheter may be placed in or near athrombus and the clot periodically sprayed (or pulsed) with athrombolytic agent which facilitates clot dissolution. Usingintermittent spraying of thrombolytic agents may enable the use of lessdrug over a shorter time period to effect for thrombolysis when comparedto the more classical approach of allowing the drug to drip in or nearthe clot. But even this approach requires excessive time and drugamount. In addition, the use of pulsatile injections of thrombolyticagents may result in pieces of the clot fracturing off from the mainbody of the clot and causing an embolism which is a danger faced byinterventionalists performing this procedure. It is, therefore,desirable to provide an improved catheter for delivering thrombolyticagents which reduce the time and amount of pharmaceutical agent requiredfor thrombolysis and which reduces the danger of embolism.

[0008] Stiles, in U.S. Pat. No. 4,692,139 (incorporated herein byreference), describes a catheter for removing obstructions frombiological ducts which transmits ultrasonic vibrations to theobstruction to facilitate lysis. Stiles' catheter has means foradministering a lysing agent and simultaneously administering ultrasonicvibrations to obstructing material forward of the catheter tip. TheStiles catheter has a vibrating probe which probe (when the catheter isdeployed within a vessel) projects from the tip of the catheter. Thereis no teaching of any advantages to be gained by either (a) vibratingthe catheter (as opposed to a probe housed within a catheter), or (b)using low frequencies (frequencies below 1000 Hz). Further, Stilesteaches the use of vibrational frequencies in the range “of at least 60KHz.” The vibrational frequency employed to effect lysis is an importantissue. It is noted that at the frequencies suggested by Stiles'teaching, the wavelength of ultrasound in the probe is$\lambda = {\frac{v}{f} < \frac{1000}{f} < \frac{1000}{60,000}}$

[0009] or λ<{fraction (1/60)} foot. Thus, in Stiles' catheter there arenormally many wavelengths of ultrasound between the ultrasonic sourceand the probe tip. Wherever the probe tip touches the surroundingaspiration tube walls and/or aspirate, energy will be lost due toheating. Thus, it is difficult or impossible to control the amount ofultrasonic vibratory energy reaching the tip of the probe. Depending onthe amount of loss of ultrasonic vibrational energy that occurs alongthe length of the probe (which, of course, depends on the amount ofaspirate in the aspirator tube and the amount of mechanical contactbetween the probe and the surrounding walls) the energy actuallydelivered to tissue at the probe tip may either ablate or weld tissue,emulsify an obstruction or be insufficient to have any effect on anobstruction.

[0010] Lower frequency vibrations (less than 100 Hz) have wavelengthsgreater than one foot. The amplitude and, therefore, the energy of thelow frequency vibration delivered to the tip of a catheter is much morepredictable at the lower frequencies and enable more accurate dosimetry.This is because the vibratory loss to surrounding tissue is due touniform frictional losses along the length of the elongate member(inserted catheter). Stiles' probe, which vibrates at ultrasonicfrequencies as noted above, is housed within an aspiration tube where itmay unpredictably be loaded by contact with any aspirate that may bepresent or the surrounding catheter walls. That is, the undesirablecoupling of vibratory energy out of the Stiles' probe is unpredictable.It would be desirable to provide an interventional catheter having astructure wherein the vibrating element contacts the tissue along itsentire length.

[0011] All of the prior art thrombolysis catheters have specifiedultrasonic frequencies (above audible frequencies) when advocatingadjunctive vibratory waves to assist thrombolysis. Perhaps this is dueto the availability of compact solid state crystals that oscillate ormay be driven at these frequencies. Perhaps it is the belief that thesefrequencies assist in “emulsifying” an obstruction such as a thrombus.Whatever the reason, the present teaching surprisingly shows that theapplication of low frequency mechanical vibrations facilitate thrombusdisintegration. Even more surprisingly, this is true even in the absenceof an exogenous lysing agent.

SUMMARY OF THE INVENTION

[0012] While the invention is best understood and taught by makingreference to the invention in context of a particular application suchas the treatment of vascular thrombosis, it is the object of the presentinvention to provide a catheter (herein alternatively referred to as a“motion catheter” or a “vibrating catheter”) that can be placed in ablocked lumen in the body and, by either utilizing the motion of thecatheter alone or the catheter motion in combination with the dispensingof a medicament suitable for dissolving such blockage, dislodge or morepreferably, dissolve said blockage. This motion catheter, which may besimply a moving wire, can be used alone for blockage removal or with alysing agent to dissolve the blockage. Most preferably, both motion anddispensing are used in combination to effect blockage removal.

[0013] The objects of this invention are achieved, in general, byproviding a vibrating wire, or alternatively, a vibrating catheter thathas an open lumen for delivery of said lysing agents. The vibratingcatheter may have one or more directional channels for delivery of alysing agent which channel(s) are attached to a pump so that delivery ofsaid lysing agent can be controlled with respect to delivery time anddelivery rate of the lysing agent.

[0014] Because blockage of lumens in the body are often times visualizedwith image enhancement devices, the catheter of the present invention isconveniently placed by means of fluoroscopy, ultrasound or the like. Themotion catheter may be placed in the body in any tubular tissue inproximity to said blockage so that the motion of the catheter willdislodge or preferably dissolve the blockage.

[0015] A specific application of the aforementioned motion catheter isthe dissolution of blood clots or thrombi with or without the use of alysing/thrombolytic agent such as urokinase, streptokinase or a similarlysing agent. If the distal tip of the motion catheter is placed injuxtaposition to a blood clot (proximal, distal, inside or adjacent tothe clot), the low frequency (1-5000 Hz) motion of the catheterfacilitates the dislodgment by mechanical agitation of the thrombolyticclot. Dissolution may be achieved if the vibrating catheter alsodispenses a thrombolytic agent. Usually the thrombi are located in anartery. As a thrombus dissolves, it is desirable that the tip of themotion catheter be moved (with regard to its originalplacement/location) to keep the tip in juxtaposition with the clot andto further facilitate the dissolution of the thrombi.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016]FIG. 1 is a schematic view of a preferred embodiment of the motioncatheter of the present invention.

[0017]FIG. 2 is a cross-sectional view of the distal treatment tip ofthe catheter of FIG. 1 along line 2-2.

[0018]FIG. 3 is a cross-sectional view of the motion catheter of FIG. 1taken near the proximal end of the catheter along line 3-3.

[0019]FIG. 4 is a longitudinal cross-sectional view of the proximal endof the motion catheter of FIG. 1 taken along line 4-4.

[0020]FIG. 5 is a schematic perspective view of the preferred embodimentof the motion catheter of the present invention wherein the distaltreatment tip of the catheter of the present invention is embedded inthe obstruction (shown in cross-section) causing blockage of the lumen.

[0021]FIG. 6 is a schematic perspective of the preferred embodiment ofthe present invention shown in FIG. 5 wherein the motion catheter passesthrough or around the obstruction and the lysing agent (if required)emanates from the most distal portion of the catheter.

[0022]FIG. 7 is a schematic perspective view of the preferred embodimentof the present invention shown in FIG. 5 wherein the distal treatmenttip of the catheter protrudes through the clot/obstruction and thelysing agent sprays inside the clot and both proximal and distal to theclot.

[0023]FIG. 8 is a cross-sectional view of the preferred embodiment ofthe present invention in FIG. 5 wherein the distal treatment tip of themotion catheter is located proximal to the obstruction and the sprayinglysing agent delivered from the tip in a direction parallel to the longaxis of the catheter.

[0024]FIG. 9 is a perspective view of the distal tip of the preferredembodiment of the present invention shown in FIG. 5 wherein the motioncatheter is rotating or oscillating in a to-and-fro motion while thelysing agent is being dispensed.

[0025]FIG. 10 is a cross-sectional view of the preferred embodiment ofthe present invention shown in FIG. 5 wherein the lysing agent isdispensed by holes in the distal tip and is directed within and/or underthe body of the obstruction.

[0026]FIG. 11 is a cross-sectional view of a second preferred embodimentof the present invention wherein an inflatable vessel occluder near thedistal tip of the catheter blocks the flow of blood around the outsideof the catheter thereby forcing the blood to flow through a particlefilter housed within a perfusion channel within the catheter.

[0027]FIG. 12 illustrates a prospective view of an aspiration embodimentof the present invention.

[0028]FIG. 13 illustrates the distal end of an aspiration embodiment ofthe present invention.

[0029]FIG. 14 illustrates an alternate embodiment of an aspirationdevice of the present invention.

[0030]FIG. 15 illustrates an additional alternative embodiment of anaspiration device of the present invention.

[0031]FIG. 16 illustrates the use of a balloon mechanism with thecatheter of the present invention.

[0032]FIGS. 17 through 20 illustrate various embodiments of a filtertrap with and without the use of the aspiration device of the presentinvention.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

[0033] Turning now to FIG. 1, a preferred embodiment of the motioncatheter of the present invention is generally indicated at the numeral10. The catheter 10 has a proximal end 11 and a distal or treatment end12. The proximal end 11 matingly engages a vibrating member 16 whichvibrating member 16 is driven by an oscillator 15. The catheter 10 mayhave one or more lumens extending from the proximal end to the distalend. One lumen, which is optional, is a guidewire lumen which enters thecatheter through the guidewire lumen port 13 and exits the catheterthrough the distal tip 12. A second lumen, having an entry portgenerally indicated at 14, extends the length of the catheter to thedistal tip 12 and is used as a conduit for transporting a lysing agentor other compatible fluid (e.g., saline) from a reservoir (not shown) tothe distal tip 12 of the catheter 10.

[0034] The distal tip 12 of the catheter 10, which may be radiopaque, isshown in cross-section in FIG. 2. A lysing agent lumen 21 extends thelength of the catheter connecting the lysing agent entry port 14 withdispensing holes near the distal tip 12. There may be one or more holessurrounding the tip 12, which holes are in fluid communication with thelysing agent lumen 21. The guidewire lumen 22, which is optional,enables the use of the catheter with a guidewire. The guidewire (notshown) may be introduced into the vessel in which the catheter is to beinserted for removing blockage. The abnormal narrowing or constrictionof a passage or lumen such as results from a clot lodged in a bloodvessel is called a stenosis. The guidewire is advanced, usually by meansof x-ray, until it reaches the point of stenosis. The guidewire may thenbe either forced through the stenosis or it may terminate at thestenosis. The catheter 10, may then be inserted over the guidewire andadvanced so that the distal tip 12 of the catheter is in juxtapositionwith the blockage. While for many applications the presence of aguidewire lumen is necessary, for other applications it is not required.A pump (not shown) may be used to force a lysing agent into the lysingagent lumen 21 through the entrance port 14.

[0035] It is known in the prior art to be advantageous to have anelement within an intravascular catheter capable of vibration at highfrequencies. Such catheters normally require the element to vibrate atultrasonic frequencies to effect the result desired. Accordingly, suchcatheters employ a titanium wire coupled to an ultrasonic generator suchas a piezoelectric crystal which causes the wire to vibratelongitudinally at ultrasonic frequencies. In these instances, theultrasonic energy is transferred to the medium surrounding the vibratingelement and is used to cause cavitation at the tip of the catheter,which cavitation may cause the disruption of the blockage.Alternatively, an ultrasonic transducer may be placed at the tip of thecatheter to emit ultrasonic waves laterally therefrom and receivereflections from the walls of the surrounding vessel thereby providingan ultrasonic image of the vessel wall. The use of ultrasonicfrequencies produces heat, both along the wall of the catheter and atthe tip which requires a cooling fluid. In addition, titanium must beused in order to prevent fracture of the wire.

[0036] In the present invention, the entire catheter 10 is coupled to asource of vibrational energy 16 driven by an oscillator 15 operating inthe range of 2 to 1000 oscillations per second. These low frequencyvibrations transmit along the catheter to its distal tip 12 providing amechanical motion of the tip. Such mechanical motion can be used to mixa lysing agent with a blockage near the distal tip. The vibrating agent16 (FIG. 1) is inserted into the proximal end of the motion catheter 10as shown in greater detail in FIG. 4. The proximal end 11 of thecatheter 10 matingly engages the oscillating element 16. The oscillatingelement 16 reciprocates in the direction of the long axis of thecatheter 10. Alternatively, the oscillating element 16 may rotateto-and-fro causing a back and forth rotary motion along the wall of thecatheter which is translated to the tip. Or a to-and-fro motion may beused in combination with a back and forth translational motion to effecta wobbling motion at the tip. The use of such motion in combination withthe dispensing of a medicament such as a lysing agent at the tip of thecatheter is illustrated in FIGS. 5 through 10.

[0037] In FIG. 5, the distal tip 12 of catheter 10 is shown advancedinto a blood vessel 55. The blood vessel inner wall 55 is surrounded bytissue generally indicated by 57. An obstruction 51 in the vessel ispenetrated by the distal treatment tip 12 of the catheter 10. Once tip12 of the catheter 10 is within the obstruction 51 (such as a bloodclot) a lysing agent 53 is dispensed from the holes 58 near the tip ofthe catheter by means of pumping the lysing agent 53 from a reservoir(not shown) through the lysing agent lumen 21. At the same time, themechanical motion of the tip, generally indicated at 54, is induced inthe distal tip of the catheter by means the vibrating element 16. Thecombination of lysing agent 53 emanating from holes 58 in the distal tip12 of the catheter 10 in combination with the vibratory motion 54 of thedistal tip of the catheter assists in the penetration of the lysingagent into the obstruction 51, and provides an advantage over prior art.

[0038] Alternatively, the distal tip 12 of the catheter 10 may beinserted into the blockage 51 and passed completely therethrough, asshown in FIG. 6, so that the very distal-most portion of the distal tip12 extends beyond the obstruction 51. In such an event, motional waves54 may be used in combination with the release of a lysing agent 53 fromholes 58 in the distal tip to facilitate dissolution of the blockage 51.This may be particularly advantageous in the event that plaque 56 iscovering a portion of the wall 55 of the vessel.

[0039] As shown in FIG. 7, it is also possible to have a plurality ofholes 58 dispensing the lysing agent 53, both distal to the obstruction51 and interior to the obstruction. Such a combination of vibrationalmotion and spraying of lysing agent into the blockage facilitates therapid disruption of the blockage 51.

[0040] In FIG. 8, the distal tip 12 is advanced until it is injuxtaposition with the proximal end of the blockage 51. When the distaltip is in position, the vibrational waves 54 in combination with therelease or spraying of lysing agent 53 affect the dissolution of theblockage 51.

[0041] Up until now, we've been referring primarily to vibrationalmotion in the tip of the catheter that is axial oscillatory motiongenerally in the direction of the axis of the catheter. FIG. 9 shows arotary motion which may be imparted to the tip of the catheter byapplying an oscillating rotary motion to the proximal end of thecatheter. The arrows in FIG. 9 show the rotation of various elements ofthe tip of the catheter with respect to adjacent elements of thecatheter. The catheter 10 is a flexible structure and these rotationalwaves can travel down the catheter changing direction. Such rotarymotion, particularly when the tip 12 is embedded within the blockage 51,may be particularly advantageous for facilitating the penetration oflysing agent 53 sprayed from the holes 58 in the distal tip 12 of thecatheter 10. The rotational arrows are generally indicated at 58.

[0042]FIG. 10 shows a translational motion which can be used incombination with the rotary motion of FIG. 9, which combination ofmotions may cause the tip 12 of the catheter 10 to “wobble” or “wiggle”causing mixing and enabling the lysing agent 53 to more rapidly permeatethe obstruction 51 facilitating dissolution thereof.

[0043] During the dissolution process, fragments of the obstructingthrombus may break loose and obstruct the vascular system at once ormore points remote from the original obstruction. A second preferredembodiment of the catheter of the present invention which is especiallydesigned to prevent the dissemination of such fragments to other pointsin the vascular system is shown in FIG. 11. In this second preferredembodiment the catheter 10 has a coaxial inflatable member 59 on theouter surface thereof between the holes 58, through which holes lysingagent (not shown) is sprayed, and the distal tip 12 of the catheter 10.A perfusion channel (not shown) housed within the body portion of thecatheter 10 is coextensive with the portion of the catheter betweenfenestrations 60 and 61 in the outer wall of the catheter 10 providingfluid communication therebetween. Blood enters the perfusion channel(not shown) through the proximal fenestration 60 in the directionindicated by arrow 60(a). Any fragments of thrombus entrained in theblood as the blood enters the proximal fenestration 60 will pass intothe catheter perfusion channel. A particle filter (not shown) isdeployed within the perfusion channel to remove such fragments beforethe blood exits the perfusion channel through the distal fenestration 61as indicated by arrow 61(a). The filter (not shown) is in-line with theperfusion channel connecting fenestrations 60 and 61 and can be apolymeric or metallic mesh or “birds nest” or a filter of the type usedto remove fat cells from an aspirate described in U.S. Pat. No.4,834,703 to Dubrul, et al., (incorporated herein by reference). Such afilter must be in-line with the perfusion channel and coextensive withat least a portion thereof to effectively remove fragments of thrombusand any other unwanted particulate debris from the perfusate 60(a) and61(a).

EXAMPLE

[0044] To prove evaluate the effectiveness of the present invention, anin vitro experiment was performed to evaluate the advantage, if any, ofusing the motion catheter to disburse clots rather than existingtechnology. Blood clots were created in a test tube. The weight of eachclot was measured prior to experimentation. The clots were then treatedwith urokinase at a rate of 5000 IU/ml for 5 minutes to a total of15,000 IU. The clot (thrombus) weights were measured initially andfinally to determine the amount of lysing that had taken place. One ofthe groups (Group 1) was used as a control. Nothing was done to theGroup 1 thrombi except initial and final weighing. Another group (Group2) was treated with the same amount of lysing agent, but the lysingagent was dispersed through the motion catheter while the catheter wasbeing very slowly vibrated, the catheter was placed proximal to the clotin similar fashion as was the aforementioned group. In Group 3, themotion catheter was placed in the clot as in Groups 1 and 2, but theurokinase was pulsed into the clot and no motion was applied to thesystem. In Group 4, the lysing agent was pulsed into the clot as inGroup 36, but a slow (low frequency) vibratory motion was applied to themotion catheter Group 5 clots were treated with saline and slowvibration. In Groups 2, 4, and 5 (Groups with a motion applied to themotion catheter) the amount of lysing of the clot/thrombus was greatlyincreased as determined by the difference in weight of the clot/thrombusbefore and after the one hour treatment. Those results are tabulated inTable 1 where the percentage of lysing is the difference between theinitial and final weight of the clots divided by the initial weight, thequotient multiplied ×100. TABLE I Group 1 4.5% Lysing Group 2 68% Group3 26% Group 4 45% Group 5 45%

[0045] From the foregoing data it is clear that low frequency vibrationwith administration of a lysing agent (Group 2) give the best results.Surprisingly, the Group 5 clots (no lysing agent) that were subjectedonly to a low frequency (1-1000 Hz) vibrating member in the presence ofsaline exhibited substantial dissociation under the conditions of theexperiment. This suggests that the introduction of a simpleintravascular wire or similar elongate member vibrating at lowerfrequencies (<1000 Hz) into a blocked vessel may be useful fordisrupting clots.

[0046] The invention will now be described with respect to FIGS. 12through 15. An aspiration device generally indicated by the numeral 100,is shown with respect to FIG. 12. The aspiration device 100 includes asuction mechanism 102 located at the proximal end 11 of the motioncatheter 10. The aspiration device 100 additionally includes an outersleeve 104, as shown more clearly in FIG. 13. The outer sleeve extendsfrom the proximal end 11 to the distal end 12 of the device 10.

[0047] During, after, or before the obliteration of the atheroma orother obstruction in the blood vessel, small particles represented byfragments 106 exist within the blood vessel. As is well known, thesefragments can cause extreme health difficulties such as stroke,ischemia, collateral vessel blockage and the like. It is thus,advantageous to remove such particles 106 from the blood vessel. Theaspiration device 100, which activated, causes a suctioning, or lowpressure, to be developed at the proximal end drawing blood in adirection of the arrows 108. The aspiration device is activated by thesuction mechanism 102. The suction mechanism 102 includes a chamber 110and a plunger 112. When the plunger 112 is pulled away from the chamber110, a low pressure area or vacuum is created in a lumen of the catheter10. As noted below, this causes the blood flow to proceed from thedistal end to the proximal end. Other vacuum sources such as amechanical pump, or an electro-mechanical pump, may also be used as thesuctioning mechanism 102, to create the low pressure area.

[0048] It will also be appreciated that, while it is not shown in FIG.12, a third port could be added comprising an injection port. Theinjection port, while not shown here, is shown in the earlier fileddrawings connected with this matter, specifically FIG. 1 of U.S. Pat.Nos. 5,498,236 and 5,380,273. Additionally, the motion catheter 10 mayinclude distal end 12 having an infusion port such as infusion port 61,as described with reference to FIG. 11 of the above identified patents.

[0049] It will be appreciated that the injection port and the aspirationport may be activated independently and simultaneously. Thus, whilefluid may be moved up and through the catheter from the distal end tothe proximal end, it may also be appreciated that fluid may also bemoved down and through the proximal end 11 through the distal end 12using the injection port. In this way, while simultaneously aspirating,a fluid such as a medicament, for example saline or sterile water, maybe injected into the patient's blood vessel simultaneously with theaspiration process. Additionally, it will be appreciated that fluid ofany kind can be moved in either direction through the catheter usingaspiration and infusion including fluid such as a contrast fluid.

[0050] It will be appreciated that FIG. 11 of the above identifiedpatents, noted particularly at U.S. Pat. No. 5,498,236, col. 6, lines 50through 57, and at col. 6, line 65 through col. 7, line 12 and U.S. Pat.No. 5,380,273, col. 6, line 58 through col. 7, line 25, specificallydisclose polymeric, metallic mesh, or birds nest filter described withrespect to aspiration and the like. A filter such as the one describedabove, or filter cartridge as specifically referred to in U.S. Pat. No.4,834,703, may be inserted within the outer sleeve 104 coaxially withthe catheter. The filter cartridge, or filter, traps the particulatematter or particles 106, thereby removing the same from the blood vesseland consequently from the blood stream.

[0051] As shown in FIGS. 12 and 13, the motion catheter 10 may beactivated during aspiration. It may be desirable to remove particulatematter 106 as the tip is in motion to either vibration or rotation.Alternatively, the aspiration device 100 may be activated both after andbefore activation of the motion catheter.

[0052] With respect to FIG. 14, there is shown another embodiment of theaspiration device 100, wherein the distal end 12 of the motion catheter10 includes the distal end having fenestrations. In this embodiment, thein-line polymeric filter and/or filter cartridge would be insertedwithin the motion catheter itself to trap the particulate matter 106.The fenestrations 114 are shown in FIG. 14 as being generallyrectangular in shape. It will be appreciated that a variety of shapes,sizes, and styles may be appropriate depending upon the particularfunction, blood flow, and level of force of the aspiration device 100.Similarly to the previously discussed embodiment shown in FIG. 13, theembodiment shown in FIG. 14 having fenestrations 114, allow theparticulate matter to enter the fenestrations as a result of the lowpressure being created by the activation of the aspiration device 100,and thereby removed by the blood stream through the in-line polymericfilters as discussed above.

[0053] With respect to FIG. 15, there is shown a third embodiment of theaspiration device 100 in accordance with this invention. In theaspiration device of FIG. 15, the outer sleeve 104 includes an occludingmechanism 116 which prevents blood from preceding around the occludingmechanism 116 and causes blood flow to enter the proximal end of theouter sleeve 104. Similar to the previously discussed embodiments ofFIGS. 13 and 14, the occluding mechanism 116 operates to force bloodflow to an area where an in-line polymeric filter or filter cartridgemay trap the particulate matter 106, thereby removing it from the bloodvessel and consequently the blood stream.

[0054] It will be appreciated that a variety of other filters notdescribed herein may be used. For example, the filters may comprise avariety of different shapes and sizes and may be located in slightlydifferent positions on the catheter.

[0055] The occluding mechanism 116 comprises an exemplary embodiment, anangioplasty type balloon which is selectively inflated to cause ablockage in the blood vessel as shown clearly in FIG. 15. Otheroccluding mechanisms of course are within the scope and spirit of thisinvention.

[0056] Also, it will be appreciated that an occlusion balloon, orcentering balloon, may also be used in place of the angioplasty typeballoon. The occlusion or centering balloon is distinguished from theangioplasty balloon because it does not inflate to a predeterminedsized. Rather the occlusion balloon continues to increase in size themore it is inflated. Also, the occlusion balloon conforms itself to theshape and size of the inner vessel wall. In some instances, it may wellbe preferable to use the occlusion balloon as opposed to the angioplastytype balloon. It will be understood herein that when referring to theangioplasty balloon below, that other types of balloons including theocclusion or centering balloon, may well be substituted in its place.

[0057] Similarly with respect to FIGS. 13 and 14, the aspiration deviceof FIG. 15 may be used before, after, or during activation of the motioncatheter 10.

[0058] With respect to FIG. 16, there is shown another embodiment of themotion catheter 10 in accordance with this invention. In thisembodiment, the motion catheter 10 includes an angioplasty-type balloon118 at the distal end 12. The angioplasty-type balloon 118 is formed, asis conventional in the field and more particularly as shown anddescribed in U.S. Pat. Nos. 4,922,905, 4,838,268, 4,808,164, and4,707,670, which are specifically incorporated herein by reference, andrepresents a typical angioplasty-type balloon. As noted above, anocclusion balloon such as those identified in U.S. Pat. Nos. 5,637,086,5,222,970, 5,074,869, and 4,130,119, which are also specificallyincorporated herein by reference, may be substituted for theangioplasty-type balloon.

[0059] In the embodiment shown in FIG. 16 showing the angioplastyballoon 118, the motion catheter may be activated before, during, orafter, balloon expansion. It is believed that such motion of theangioplasty balloon is particularly useful in relieving the blood vesselobstruction. It will be appreciated that the various elements, shown inFIGS. 12 through 15, may be combined or used alternatively with theembodiment shown in FIG. 16 within the spirit and scope of thisinvention. However, it is not necessary for the beneficial effects andadvantages of the embodiment shown in FIG. 16 to provide the alternativestructures shown and described in such combinations.

[0060] With respect to FIGS. 17 through 20, there is shown an alternateembodiment of the motion catheter device 10 having a distal end 121 anda coaxial filter trap 120. As similarly shown with respect to the '273and '236 patents described above, the filter trap 120 is deployable andexpandable as shown in FIGS. 17 through 20.

[0061] In FIG. 17 the filter trap is in its initial stage of deployment.In FIG. 18 the filter trap has been fully expanded. Additionally, inFIG. 18 there is shown the filter trap 120 used in combination with theoccluding mechanism 116. Using a combination of these devices providesthe invention with the ability to trap particulate matter 106, whetherit flowed against or with the arrows 108. It will be readily appreciatedthat any particulate matter traveling in the direction opposite of thearrows would be trapped within the filter trap 120. The filter trap 120is made of polymeric mesh and can be expanded to a variety of shapes andsizes. The device 10 includes activation mechanism (not shown) which canreadily expand or contract the filter trap 120.

[0062] It will be appreciated that the inflatable coaxial structuredescribed with respect to the '273 and '236 patents can, in fact, definea filter such as the ones described above. It will also be appreciatedthat a combination of the inventions taught by the '236 and '273 patentsand the disclosure herein can be combined. In fact, an occluding elementcould be distal to the distal end of the catheter 12 with a filter beingin-line in an aspiration device. In this way, the particulate matter isprevented from flowing down stream by the occlusion mechanism while theaspiration device is activated causing the particulate matter to bedrawn back into the inflatable coaxial filters. Thus, the fluid downstream of the occluding mechanism would be relatively free ofparticulate matter while the particulate matter would be substantiallytrapped within the coaxial filter.

[0063] Upon activation of the motion catheter, a spinning vortex iscreated. Upon the direction of the user, the particulate matter 106 canbe directed, either proximally or distally, to be trapped by the filtersystem described above. Again, the object of trapping particulate matteris accomplished. In this way, the spinning vortex causes additional andfurther particulate matter to be trapped in a coaxial filter.

[0064] Additionally, polymeric shapes such as a frusto-conical shapefilter trap alternative embodiment generally indicated by the numeral122, may alternatively be employed. The filter trap 122, shown in crosssection FIG. 19, includes an outer member 124 and an inner member 126.Both filter members are connected at their distal regions 131 and 134 tothe distal region 130 of a shaft 128 which shaft is housed in hollowtube 129. The proximal regions 132 and 133 of filter trap members 124and 126 are attached to distal regions 135 and 136 of tube 129. Uponactivation both inner and outer filter members, 124 and 126,respectively, are deployed or expanded within the blood vessel. Upondeactivation, both filter members are contracted and fit snugly alongshaft 128. The dual filter has the purpose of (1) sealing against thevessel wall, (2) capturing large and small particles and the preventionof dissemination of such fragments, (3) the centering of the catheterduring motion, (4) capturing and holding particulate matter fordissolution, and (5) capturing of particulate matter allowing blood orsmaller particles to flow through, whereby, at the end of the procedure,the filter trap is un-deployed and particulate matter is removed.

[0065] The filter shaft system, upon trapping the particulate matter106, can either remain deployed until the blood flow causes theparticulate matter 106 to be dissolved or can be contracted and thenremoving the device 10 from the blood vessel and then removing thetrapped particulate matter 106 will thus remove the particular matterfrom the blood system.

[0066] The aforesaid specification taken in connection with the drawingsand the aforementioned experiment sets forth the preferred embodimentsof the present invention. The embodiments of the invention disclosedherein are the best modes contemplated by the inventors for carrying outtheir invention in a commercial environment, although it should beunderstood that various modification can be accomplished within thescope of the invention.

We claim:
 1. A device for the removal of particles from a lumen withinthe body comprising: an outer, hollow tube having a tube distal end; aninner member housed within the tube and having an inner member distalend positioned distally of the tube distal end; a porous braidedstructure having a distal part secured to the inner member distal endand a proximal part secured to the tube distal end; the braidedstructure movable from a contracted condition to an expanded conditionby moving at least one of the tube and inner member distal ends towardsthe other; and the braided structure adapted to inhibit particles frommoving completely through the braided structure when in the expandedcondition.
 2. The device as in claim 1 where said braided structure hasa porous proximal side and a porous distal side.
 3. The device a sinclaim 2 wherein said distal side has smaller pores than the proximalside.
 4. The device as in claim 3 wherein said braided structurecomprises a section of a tubular, porous braided structure havingalternating first and second braided sections, said first braidedsections, corresponding to said distal side, having pore sizes smallerthan the second braided sections, corresponding to said proximal side.5. A device for the removal of particles from a lumen within the bodycomprising: an outer, hollow tube having a tube distal end; in innermember housed within the tube and having an inner member distal endpositioned distally of the tube distal end; a porous mesh structurehaving a distal part secured to the inner member distal end and aproximal part secured to the tube distal end; the mesh structure movablefrom a contracted condition to an expanded condition by moving at leastone of the tube and inner member distal ends towards the other; and themesh structure adapted to inhibit particles form moving completelythrough the mesh structure when in the expanded condition.
 6. The deviceas in claim 5 where said mesh structure has a porous proximal side and aporous distal side.
 7. The device as in claim 6 wherein said distal sidehas smaller pores than the proximal side.
 8. The device as in claim 7wherein said mesh structure comprises a section of a tubular, porousmesh structure having alternating first and second mesh sections, saidfirst mesh sections, corresponding to said distal side, having poresizes smaller than the second mesh sections, corresponding to saidproximal side.